510(k) · Cleared
ClearedCook Vascular Vital-Ject Power Injectable Safety Infusion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Vascular, Inc. · FPA Set, Administration, Intravascular
Cleared on Apr 2, 2009 as substantially equivalent to K033515 (Command Medical Products, 2004) after a 129-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- Apr 2, 2009
- Review
- 129 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K890127 (1989). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK890127 Intravascular Administration SetMulti-Med, Inc. · 1989
- 3 generations backK993848 Millennium Huber Plus Safety Infusion SetMillennium Medical Distribution, Inc. · 2000 · Recalled
- 2 generations backK013871 Lifeguard Safety Infusion SetHorizon Medical Products, Inc. · 2002 · Recalled
- 1 generation backK033515 Huberpro Safety Huber Infusion SetCommand Medical Products · 2004
- This deviceK083482 Cook Vascular Vital-Ject Power Injectable Safety Infusion SetCook Vascular, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K890127 | Intravascular Administration Set | Multi-Med, Inc. | 1989 | — |
| −3 | K993848 | Millennium Huber Plus Safety Infusion Set | Millennium Medical Distribution, Inc. | 2000 | 2 |
| −2 | K013871 | Lifeguard Safety Infusion Set | Horizon Medical Products, Inc. | 2002 | 3 |
| −1 | K033515 | Huberpro Safety Huber Infusion Set | Command Medical Products | 2004 | — |
| 0 (this device) | K083482 | Cook Vascular Vital-Ject Power Injectable Safety Infusion Set | Cook Vascular, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FPA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033515 | Huberpro Safety Huber Infusion SetSummary page 1…es used to manufacture these solution administration sets are the exact same as the currently legally marketed by Command Medical, HuberPROTM Safety Huber Infusion Set. (K033515). The packaged Infusion set will be supplied from Command Medical and Cook Vascular will label, sterilize and market the product.… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 5.2 years on median.
- 3 of the 10 ancestors have a recall of any class.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
The Cook Vascular VITAL-JECT Power Injectable Safety Infusion Set is intended to be used to
administer solutions and medications into vascular implant ports. When used with a power
Injectable vascular implant port, the Cook Vascular Safety Infusion Set is indicated for power
injection of contract media. For power injection of contrast media, the maximum recommended
infusion rate is 5 ml/s using contrast with a maximum viscosity of 11.8cP.
In addition, to minimize the risk of accidental needle stick after use, the attached safety guard fully
encapsulates the needle when manually activated during withdrawal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083482 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083482: Cook Vascular Vital-Ject Power Injectable Safety Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083482
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026